Hypothermia, Heart Arrest, Hemostasis, Coagulants
Conditions
Keywords
Thromboelastometry, Haemostasis, Hypothermia, Heart Arrest
Brief summary
This is a sub-study to the Time-differentiated Therapeutic Hypothermia (TTH48, ClinicalTrials.gov Identifier: NCT01689077). TTH48 compares 24 with 48 hours of therapeutic hypothermia at a target temperature of 32-34°C in survivors of out-of-hospital cardiac arrest. The overall aim of this sub-study is to examine the hemostasis in patients resuscitated after cardiac arrest and treated with 24 and 48 hours of therapeutic hypothermia Our specific aims are: * To investigate the whole blood coagulation using the rotational thromboelastometry. * To investigate the function of platelets
Interventions
Therapeutic hypothermia with a target temperature between 32-34°C.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Out of hospital cardiac arrest of presumed cardiac cause * Return of spontaneous circulation (ROSC) * Glasgow Coma Score \< 8 * Age \> 18 years and \< 80 years
Exclusion criteria
* \> 60 minutes from the circulatory collapse to ROSC * Time interval \> 4 hours from cardiac arrest to initiation of therapeutic hypothermia * Terminal illness * Coagulation disorder * Unwitnessed asystolia * Cerebral performance category 3-4 before the cardiac arrest * Severe persistent cardiogenic shock * Pregnancy * Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment) * New apoplexy or intracerebral hemorrhage * Lack of consent from the relatives * Lack of consent from the GP * Lack of consent from the patient if he/she wakes up and is relevant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clotting time in seconds, EXTEM | After 46 hours | Measured by thomboelastometry on the ROTEM® |
| Area under the curve, COL-test | After 46 hours | Platelet function will be measured using Multiplate® |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum clot firmness (mm), -EXTEM, INTEM, FIBTEM and HEPTEM | After 22 hours, 46 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
| Area under the curve, COL-test | After 22 hours and 70 hours | Platelet function will be measured using Multiplate®. |
| Area under the curve,- ADP, ASPI and TRAP-test. | After 22 hours, 46 hours and 70 hours | Platelet function will be measured using Multiplate®. |
| Time to maximum velocity (s), -EXTEM, INTEM, FIBTEM and HEPTEM | After 22 hours, 46 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
| Maximum velocity (mm/min), -EXTEM, INTEM, FIBTEM and HEPTEM | After 22 hours, 46 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
| Area under the curve, Clot stability test | After 22 hours, 46 hours and 70 hours | — |
| Area under the curve, Thrombin generation | After 22 hours, 46 hours and 70 hours | — |
| Clotting time in seconds, EXTEM | After 22 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
| Clotting time in seconds, -INTEM, FIBTEM and HEPTEM | After 22 hours, 46 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
| Clot formation time in seconds, -EXTEM, INTEM, FIBTEM and HEPTEM | After 22 hours, 46 hours and 70 hours | Measured by thomboelastometry on the ROTEM®. |
Other
| Measure | Time frame |
|---|---|
| Antithrombin in 10^3 int.units/l | After 22 hours, 46 hours and 70 hours |
| D-dimer in mg/l FEU | After 22 hours, 46 hours and 70 hours |
| Trombine time in seconds | After 22 hours, 46 hours and 70 hours |
| International normalized ratio | After 22 hours, 46 hours and 70 hours |
| Fibrinogen in mol/l | After 22 hours, 46 hours and 70 hours |
| APTT (activated partial thromboplastin time) in seconds | After 22 hours, 46 hours and 70 hours |
Countries
Denmark
Outcome results
None listed